Electrode arrangement

ABSTRACT

The invention relates to an electrode arrangement for applying of a transcutaneous electrical stimulation stimulus onto the surface of a section of the human ear, which comprises a holding element to be attached at or in the ear as well as at least one electrode, which electrode is arranged in or at an electrode carrier, wherein the holding element comprises a linear guide in which a supporting rod is arranged linear movable in the direction of a longitudinal axis (L) of the holding element and wherein the electrode carrier is arranged at the supporting rod. To obtain an improved transcutaneous stimulation the invention proposes that the electrode carrier comprises at least one carrier section on which the electrode is arranged, wherein the electrode comprises at least one cylindrical and/or spherical segment shaped and/or conical surface section.

This application claims priority under 35 USC 119 and incorporates byreference the following applications: U.S. Provisional Application No.61/681,198 filed Aug. 9, 2012; German Application No. 10 2012 014 764.3filed Jul. 25, 2012, published as DE 10 2012 014 764A1; and GermanApplication No. 10 2012 004 021.0 filed Mar. 2, 2012, abandoned.

The invention relates to an electrode arrangement for applying of atranscutaneous electrical stimulation stimulus onto the surface of asection of the human ear, which comprises a holding element to beattached at or in the ear as well as at least one electrode, whichelectrode is arranged in or at an electrode carrier, wherein the holdingelement comprises a linear guide in which a supporting rod is arrangedlinear movable in the direction of a longitudinal axis of the holdingelement and wherein the electrode carrier is arranged at the supportingrod.

It is generally known to take influence on the neurophysiological andneuroelectrical quality through invasive and non-invasive stimulation ofthe nerves and thereby on the function of the simulated nerves. Herebydifferent conditions of sickness can be treated. Numerous devices existboth for the invasive and the non-invasive stimulation.

The present invention is based upon the method of the transcutaneouselectrical stimulation of the nerves. At this method pulse currents ofdifferent current forms, amplitudes, pulse durations and frequencies areadministered through the skin on different nerves and change theirstatus parameter in an advantageous way.

An electrode arrangement of the kind which is mentioned at the beginningis known from the EP 2 026 872 B1, patented. An electrode arrangement isdescribed here which comprises a housing, which is entirely placeablewithin the pinna. From the housing two bent, wire-like sections areextending, wherein they are formed as spring-elastic carriers. Therewiththe electrode arrangement can be put into the needed position by aslight clamping in the pinna, so that the ear canal can be charged witha transcutaneous stimulus. Other stimulation devices are disclosed in DE10 2005 003 735 A1, patented as DE 10 2005 003 725 B4, and U.S. Pat. No.5,514,175.

Even though the pre-known electrode arrangement already leads to goodtreatment results, certain drawbacks turned out during the practicalexperience.

Due to natural condition that the electrode arrangements with theirelectrodes have to be built very small, the mechanical stability of therequired connections is not solved yet in an ideal way, particularly ofthe electrodes with their cable connections. Therefore it can come to aninsufficient support of the electrodes, which is promoted by the fact,that a very soft cuddly material (especially silicon) has to be employedfor the holding to achieve a sufficient wearing comfort. With arespective mechanical strain of the electrode arrangement it comesoccasionally to irreparable damages at the contacts of the electrodeswhile inserting them into the ear canal.

In addition it has been recognized as disadvantageous that it isdifficult to adjust, if necessary, a present electrode arrangement tothe individual size of the pinna respectively the ear in general. Thisleads occasionally to a high complexity or respectively to a not idealwearing comfort during inserting of the electrode arrangement.

It is furthermore disadvantageous at some pre-known electrodearrangements that the hearing can be influenced negatively.

In addition, the quality of the contact of the electrodes isoccasionally not ideal, because the areas of the skin, which areacquired from the electrodes, are not big enough. With some of thepre-known solutions this results from the way, how the electrodes arearranged on a carrier element.

Furthermore it is desired to provide measures to enable an adjustment ofthe stimulus device to an individual ear with a simple and competitivemanner, despite the standardization of the stimulus devices.

Thus, it is an object of the invention to develop an electrodearrangement of the generic kind in such a way to stay abreast of thementioned disadvantage. Thus, an electrode arrangement shall be proposedwhich allows the disposing of the electrode arrangement in an easy andconvenient manner. Thereby, the hearing should be influenced as littleas possible negatively during wearing of the electrode arrangement. Thecontact quality of the electrodes should be improved by an optimizeddesign.

The solution of this object by the invention is characterized in thatthe electrode carrier comprises at least one carrier section on whichthe electrode is arranged, wherein the electrode comprises at least onecylindrical and/or spherical segment shaped and/or conical surfacesection.

Thereby a cylindrical and a spherical segment shaped surface section ora conical shaped and a segment shaped surface section is preferablyprovided.

A preferred solution provides, that the electrode in its area, which isfacing the carrier section, is formed cylindrically, wherein a sphericalsegment shaped section attaches to the cylindrical area of theelectrode, which end area is averted from the carrier section. With thissolution it can be provided moreover, that the transition of theelectrode from its cylindrical region to the carrier section is formedby a conical region, wherein the cylindrical region has a biggerdiameter than that one of the carrier section.

The electrode carrier can thereby comprises a holding section whichcomes from the supporting rod, on which end at least two carriersections pointing into different directions are arranged with therespective electrodes.

The at least one carrier sections can comprise an axle element on whichthe electrode is applied, particularly is plugged on. The electrode onthe axle element can be attached adhesive bonded, form-fitted and/or canbe fictionally engaged.

An alternative solution provides that the at least one carrier sections,preferably together with the holding section, is formed by an injectionmolding process, wherein the electrode is connected with the carriersection in situ by the injection moulding process.

The holding section can comprise a longitudinal axis which encloses anangle to the longitudinal axis of the holding section, which is between20° and 80°, preferably between 40° and 70°.

A preferred embodiment of the invention provides that (exactly) twocarrier sections and/or axle elements are provided, which are arrangedbelow an angle, which is between 140° and 180°, preferably between 165°and 175°.

Furthermore it can be provided, that the holding element comprises aresting part, that is designed and provided for resting in the Cavumconchae of the ear.

The electrode carrier is mostly arranged to an axial end of thesupporting rod.

The electrode carrier comprises preferably at least one stimulationelectrode and at least one reference electrode, particularly shaped asan electrode head.

The linear guide of the holding element can be built by a recess, whichcomprises an even form, particularly a circular form, in a section thatis perpendicular to the longitudinal axis along the longitudinal axis;then, the supporting rod comprises preferably a circular profile atleast along a part of its extension.

Additionally or alternatively fixation means can also be provided, whichblock the relative linear position between the supporting element andthe supporting rod, i.e. which prevent the linear shift by the linearguide.

Furthermore spring means can be arranged between the linear guide andthe supporting rod so that the supporting rod can be elastically biasedrelative to the linear guide in direction to the longitudinal axis.

In general it can be provided, that a desired flexibility of theelectrode carrier will be reached relatively to the holding elementthrough relevant methods. The mentioned integration of a spring elementis just a possibility here. Through adequate constructive methods it canbe achieved that the flexibility respectively the spring constant lieswithin a desired region. In doing so it is possible for example, toenforce a section of the supporting rod through a metallic flat springand at the same time to take back the material of the supporting rod inthis region or to do entirely without it. The flat spring enables aspring flexibility into a defined direction while the connection betweenthe holding element and the electrode carrier stays firmer in other loaddirections.

From the above mentioned information it is understandable, that thedefinition of the “supporting rod” is to be interpreted broadly and doesnot limits itself only to classical rod formed structures.

In its axial end region where the electrode carrier is arranged, thesupporting, rod can comprise furthermore at least one collateral housingor at least one collateral cut to reduce the bending stiffness of thesupporting rod in a direction perpendicular to the longitudinaldirection within the axial end region. The adjustment of the electrodecarrier to the topography surface of the skin which is to be stimulatedwill be thereby facilitated.

The ring shaped section of the resting part can comprise an interruptionat at least one location of the circumference. Thereby it can beachieved that a simplified adjustment of the circular ring shapedsection is given to the resting area within the ear at different earsizes.

The parts of the electrode arrangement consist preferably of a softmaterial—as far as the contact to the skin is given—, wherein it isspecifically thought of are elastomere material, especially at siliconor a material, which comprises silicon. Meanwhile the electrode head andthe supporting rod consist preferably of a thermoplastic or duroplasticsynthetic material, for example of polyurethane.

It shall be mentioned, that the suggested electrode arrangement can alsocomprise only one electrode. It is possible that a separate referenceelectrode will be employed, which will be placed outside of theelectrode arrangement (e.g. behind the ear) and which is in electricalconnection to the simulation device. It is also possible that indeed twoor more electrodes exist—like in the demonstration example—but that afurther reference electrode can be employed outside of the electrodearrangement.

A further embodiment provides that the electrode arrangement is suppliedwith an acoustic transmitter (loud speaker), preferably in the region ofthe resting, part respectively of its ring shaped section. Thereby itwill be possible to feed the user also with acoustical signals duringthe electro stimulation, which can also happen for entertainmentpurposes.

It is beneficial that a quite stable construction can be reached throughthe suggested embodiment of the electrode arrangement withoutinfluencing the wearing comfort negatively. The electrodes will be keptstable and reliable in the necessary position as they are arranged viathe supporting rod at the relative stable holding element.

Through the dyadic construction it is by the way possible to combine thesupporting rod including the electrode head at the one side with theholding element on the other side. This opens the possibility to combinedifferent sized elements with each other. A preferred deliveredembodiment provides therefore more than one supporting rod including theelectrode head and/or more than a holding element. The user can thenchoose and join the elements according to the ideal size of hisproportions to have an ideal fitting electrode arrangement in disposal.

In particular the holding elements can be adjusted therefore todifferent sized ears respectively different ear forms in an easy way.The electrode head respectively the electrodes lay therefore always uponthe skin with a defined pressure.

In the drawings embodiments of the invention are depicted. It shows:

FIG. 1 in a perspective view an electrode arrangement according to theinvention,

FIG. 2 the electrode arrangement according to FIG. 1 seen in a frontview,

FIG. 3 in a perspective view an electrode arrangement according to FIG.1, looking at it from underneath,

FIG. 4 in a top view the front section of the electrode arrangementaccording to FIG. 1,

FIG. 5 the electrode arrangement according to FIG. 1, seen in a frontview,

FIG. 6 in a perspective view the front section of the electrodearrangement according to FIG. 1, wherein the electrodes themselves aredemounted,

FIG. 7 the side view of the front section of the electrode arrangementaccording to FIG. 1,

FIG. 8 the side view of the front half of the electrode arrangementaccording to FIG. 1 with a first embodiment of a ring shaped contactelement,

FIG. 9 the side view of the front half of the electrode arrangementaccording to FIG. 1 with a second embodiment of a ring shaped contactelement,

FIG. 10 the side view of the front half of the electrode arrangementaccording to FIG. 1 with a third embodiment of a ring shaped contactelement,

FIG. 11 in a perspective view the electrode arrangement according toFIG. 1,

FIG. 12 in a perspective view the front part of the electrodearrangement according to FIG. 1, seen from another direction,

FIG. 13 the view of an oar with an electrode arrangement, which isinserted into the ear,

FIG. 14 the depiction according to FIG. 13, seen from another direction,

FIG. 15 the side view of the electrode arrangement according to FIG. 1,

FIG. 16 a a partial sectional view of a resting part of the electrodearrangement with a ring shaped contact element according to a firstembodiment,

FIG. 16 b a sectional view of the ring shaped contact element accordingto a second embodiment,

FIG. 16 c a sectional view of the ring shaped contact element accordingto a third embodiment and

FIG. 17 a schematically side view of latching means, which are arrangedeffectively between a holding element and a supporting rod of theelectrode arrangement.

In FIG. 1 an electrode arrangement 1 is depicted in form of anotoplastic, which can be inserted into a human ear 2 which is depictedin FIG. 13 and FIG. 14 respectively, to conduct a transcutaneouselectrical stimulation of the skin surface in the region of the ear.

With the electrode arrangement 1 a transcutaneous electrical stimulationof the nerves can be conducted precisely upon a surface region of theear. For this purpose the electrode arrangement comprises a stimulationelectrode and a reference electrode (s. below), between which anelectrical potential is produced; the therefore needed means aresufficiently known from the state of the art, so that they won't have tobe described any further here. It is referred exemplarily and explicitlyto DE 10 2005 003 735 B4, patent of the applicant.

The electrode arrangement 1 has a holding element 3 as well as asupporting rod 8 as essential construction components. The supportingrod 8 carries at one of its axial ends via a connection element 22 anelectrode carrier 6 which is equipped with two electrodes 4, 5, that isto say with a stimulation electrode 4 and a (identically constructed)reference electrode 5. The electrode carrier 6 holds both electrodes 4,5 on a desired distance and is shaped as a bridge element between theelectrodes 4, 5. The holding element 3 has a central section which isdominated from a linear guide 7 which is built out of sections of theparts 3 and 8. In this connection it is about a material section thatextends itself in a longitudinal direction L with a form such as a rod,in which a circular recess 23 is molded.

A resting part 14 is formed at the frontal end of the holding element 3.The resting part 14 comprises a ring shaped section 15 (s. particularlyFIG. 16). The ring shaped section 15 is surrounded by a ring shapedcontact element 16 which consist of a soft synthetic material and whichlies upon the surface of the skin, as it results out of FIG. 13.

It is thereby essential that the holding element 3 is able to move thesupporting rod 8 linear into the direction of the longitudinal axis L bythe linear guide 7.

Therewith it will be possible to change the distance between theelectrode carrier 6 and hence the electrodes 4, 5 and particularly theresting part 14 and to adjust it to a desired degree.

This possibility of adjustment is used to adjust the electrodearrangement after placing into the ear 2 in such a way that they find aflexible hold in the ear 2 at a good carrying comfort.

For this it is referred to FIG. 13 and FIG. 14. Here it can be seen,that the electrode arrangement 1 has been inserted into the ear 2 and bylinear displacement of the supporting rod 8 relatively to the holdingelement 3 has been adjusted in such a way, so that the electrodearrangement 1 has clamped elastically due to the topography of the ear2. The electrode arrangement 1 has been arranged practically in thepinna P of the ear 2 in such a way that the electrode carrier 6 comes tolie within the region of the Cymba conchae Cy while the resting part 14with its ring shaped contact element 16 is borne on the region of theCavum conchae Ca. Accordingly the ring shaped contact element 16 comesto lie below the tragus T.

As a result of a (due to the material) spring flexibility of thesupporting rod 8 respectively because of a spring element which isintegrated into the supporting rod 8 if needed (e.g. spring wire) theelectrode arrangement 1 clamps itself therefore relative elastically tothe holding element 3 after the appropriate linear placement of thesupporting rod 8, so that a sufficient support is given within the ear.As shown in FIG. 13, the ring shaped embodiment of the ring shapedcontact element 14 allows an extensively undisturbed hearing sensation.

As further can be seen in FIG. 1, the supporting rod 8 is not twistablearound the longitudinal axis L relatively to the holding element 3 dueto its forming. This will be achieved by a rack shaped contour 17 whichis formed onto the supporting rod 8 and which extends into a recesswhich extends radially from the circular recess 23 of the holdingelement 3. A section of the holding element 3 is shaped furthermore asengagement element 18 (s. FIG. 17), wherein a latching means are formedby the rack shaped contour 17 on the one side and the engagement element18 on the other side, by which the supporting rod 8 can be shiftedrelative to the holding element 3 in a rattling way, i.e. stepwiselinear into the direction of the longitudinal axis L.

An essential aspect of the present invention is the design of theelectrodes 4, 5 on the electrode carrier 6. As it can be best seen inFIG. 2, the electrodes 4, 5 have a design, which is composed form acylindrical section 10 and a spherical segment shaped section 11. Alsoconical shaped sections can be provided additively or alternatively. Bythat it will be achieved that the electrodes—depending from thepressure—acquire relatively big skin contact areas, i.e. having a bigcontact surface of the skin, which accordingly promotes thetranscutaneous stimulation. The electrodes 4, 5 are shaped in accordancewith this anyhow ellipsoid or pearl shaped at least in sections. In anadvantageous way this gives an improved adjustment of the electrodes tothe given anatomy of the ear.

A possible attachment of the electrodes 4, 5 on the electrode carrier 6arise from the FIGS. 3 to 7. Accordingly, the electrode carrier 6comprises a holding section 12 on which two carrier sections 9 arearranged. Each carrier section 9 has an axle element 13—s. FIG. 6—onwhich one electrode 4, 5 can be plugged on. Hereunto the electrode 4, 5comprises a corresponding bore 24 (s. FIG. 7), so that after attachingthe electrodes 4, 5 on the axle elements 13 according to FIG. 6 thearrangement results, how it can be seen in FIGS. 3, 4, 5 and 7.

in this connection it is to say, that both carrier sections 9respectively axle elements 13 which are shown for example in FIGS. 4, 5and 6 are arranged in an angle just below 180°—in the demonstrationexample it is ca, 170°—which opens itself to the skin, so that an idealrest of the electrodes on the skin is assured. Asforesaid angle is namedin the FIGS. 4 and 6 with β.

The electrodes 4, 5 can be glued on the axle elements 13 for example.

An alternative solution provides that the electrodes 4, 5 are injectedduring the injection molding of the electrode carrier 6 including thecarrier sections 9. Then, the electrodes are therefore beneficially notinsert molded, but are arranged on a synthetic core. So, the arrangementof the electrodes is optimized for the intended purpose.

From the synopsis of FIGS. 8 to 12 and 16 a further and veryadvantageous embodiment of the invention becomes apparent: The restingpart 14 consists of a ring shaped section 15, which is surrounded by adetachable ring-shaped contact element 16. Thereby, for the contactelement 16 which consists of a soft material several forms are possible,as they are recognizable from FIGS. 8, 9 and 10 and analog also fromFIGS. 16 a, 16 b and 16 c, where the respective sectional views areshown.

The form of the ring shaped section 15 is congruent to the form of thering shaped contact element 16. A slight conical form 25 of the radialouter area of the ring shaped section 15 is provided, also a recess 26in the ring shaped section 15 is provided. The ring shaped contactelement 16 is formed congruently for this so that it can be slide on thering shaped section 15 with undercut and therefore finds here sufficienthold.

In FIG. 15 it is recognizable that the holding section 12 of theelectrode carrier 6 comprises a longitudinal axis M, which cuts thelongitudinal axis L under an angle α which is ca. 65° in the embodiment.With that the electrodes are arranged in an acute angle to the contactsurface.

As in FIG. 17 further can be seen, the engagement element 18 forms afree section of the holding element 3, which is created by cuts into thematerial of the holding element and is therefore held flexible. At theside facing the rack shaped contour 17 three teeth 19, 20 and 21 areformed on at the engagement element 18. These are arranged staggered inregard to their height (s. the heights h₁, h₂ and h₃) so that thelatching function is determined primary from the tooth 19 and that onlyby support from the teeth 20 and 21.

At the radially exterior end of the section with the rack shaped contour17 of the supporting rod 8 several holding means 27 in form of ringshaped structures are formed, which serve for that reason, to hold acable 28 (preferably with 3-lead Kevlar wire and surrounded bybio-compatible casing material) strain-relieved, which supplies theelectrodes 4, 5 with electricity. Thus, the holding means 27 serve forcable leading loops in which the cable 28 is led and strain-relieved, indoing so the cable 28 can be insert moulded also during the injectionmolding of the pieces 8, 17 and 27 which are made in one piece. At themanufacturing of the electrode carrier 6 by injection moulding the cable28 can also be insert moulded in an analog way, to achieve a hermeticsealing of all joints.

At the supporting rod 8 a connection element 22 connects itself—as aconnection section to the electrode carrier 6—, which has the functionto lead the electrode carrier 6 down from the height, in where thelinear guide 7 is arranged, to the skin surface which is to bestimulated. As already mentioned this has to be carried out so that theelectrode carrier 6 presses elastically against the skin surface andpreferably creates incidentally also a pre-load into the direction ofthe longitudinal axis L.

For this purpose it will be accessed to a material for the connectionelement 22, which comprises the desired flexibility; thus, this elementhas preferably spring elastic characteristics. It is also possible thatthe connection element 22 integrates a spring element. In thisconnection it can be for example a spring wire, which is insert mouldedduring the injection moulding of the supporting rod 8 including theconnection element 22. As for example recognizable from FIG. 1, theconnection element 22 is not ring shaped in the cross section but shapedflattened. Herewith the flexibility of the electrode carrier 6 increasesinto a direction which is perpendicular to the longitudinal axis L.

At that point the material will be chosen, if necessary the integrationof a spring element and the geometrical form of the supporting rod insuch a professional way that a desired flexibility is at hand.

LIST OF REFERENCES

-   1 Electrode Arrangement-   2 Ear-   3 Holding element-   4 Electrode (stimulation electrode)-   5 Electrode (reference electrode)-   6 Electrode carrier-   7 Linear guide-   8 Supporting rod-   9 Carrier section.-   10 Cylindrical section of the electrode-   11 Spherical segment shaped section of the electrode-   12 Holding section-   13 Axle element-   14 Resting part-   15 Ring shaped section-   16 Ring shaped contact element-   17, 18 Latching means-   17 rack shaped contour/wave shaped contour-   18 Engagement element-   19 Tooth-   20 Tooth-   21 Tooth-   22 Connection element-   23 Circular recess-   24 Bore-   25 Conical form-   26 Recess-   27 Holding means-   28 Cable-   L Longitudinal axis-   M Longitudinal axis of the holding section-   α Angle-   β Angle-   Ca Cavum conchae-   Cy Cymba conchae-   T Tragus-   P Pinna

The invention claimed is:
 1. An electrode arrangement for applying of atranscutaneous electrical stimulation stimulus onto the surface of asection of the human ear, which comprises a holding element to beattached at or in the ear as well as at least one electrode, whichelectrode is arranged in or at an electrode carrier, wherein the holdingelement comprises a linear guide in which a supporting rod is arrangedto be linearly movable in the direction of a longitudinal axis of theholding element and wherein the electrode carrier is arranged at thesupporting rod, wherein: at least a portion of the holding element isadapted to rest in a Cavum conchae of the human ear; the at least oneelectrode is adapted to fit within a pinna of the human ear; and theelectrode carrier is adapting to be disposed within a Cymba conchaeregion of the human ear; wherein the electrode carrier comprises atleast one carrier section on which the electrode is arranged, whereinthe electrode comprises at least one of a cylindrical shaped segment, aspherical shaped segment, and a conical surface section.
 2. Theelectrode arrangement according to claim 1, wherein the electrode isdesigned cylindrical in its section facing the carrier section, whereina spherical segment shaped section adjoins to the cylindrical region ofthe electrode in its end remote from the carrier section.
 3. Theelectrode arrangement of claim 2, wherein the transition of theelectrode from its cylindrical region to the carrier section is formedby a conical region, wherein the cylindrical region has a biggerdiameter than that one of the carrier section.
 4. The electrodearrangement of claim 1, wherein the electrode carrier comprises aholding section which comes from the supporting rod, on which end atleast two carrier sections pointing into different directions arearranged with the respective electrodes.
 5. The electrode arrangement ofclaim 1, wherein the at least one carrier sections comprises an axleelement on which the electrode is applied, particularly is plugged on.6. The electrode arrangement of claim 5, wherein the electrode on theaxle element is attached adhesive bonded, form-fitted and/or isfictionally engaged.
 7. The electrode arrangement of claim 1, whereinthe at least one carrier sections, is formed by an injection moldingprocess, wherein the electrode is connected with the carrier section insitu by the injection moulding process.
 8. The electrode arrangement ofclaim 1, wherein the holding section comprises a longitudinal axis (M),which encloses an angle (α) to the longitudinal axis (L) of the holdingsection, which is 20° to 80°.
 9. The electrode arrangement of claim 1,wherein two carrier sections and/or axle elements are provided, whichare arranged below an angle (β), which is 140° to 180°.
 10. Theelectrode arrangement of claim 1, wherein the holding element comprisesa resting part, that is designed and provided for resting in the Cavumconchae (Ca) of the ear.
 11. The electrode arrangement of claim 7,wherein the at least one carrier section and the holding section areformed together by the injection molding process.
 12. The electrodearrangement of claim 8, wherein the angle (α) is 40° to 70°.
 13. Theelectrode arrangement of claim 9, wherein the angle (β) is 165° to 175°.